Atopic Dermatitis Clinical Trial
Official title:
a Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis.
Status | Recruiting |
Enrollment | 420 |
Est. completion date | January 30, 2026 |
Est. primary completion date | January 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Male or female subjects aged =18=75 years old. 2. Atopic dermatitis (AD) diagnosed at least 1 year before screening. 3. Subject with eczema area and severity index (EASI) score =16, Investigator Global Assessment (IGA) score= 3, Body Surface Area (BSA) score = 10% at screening and baseline. 4. Previously received at least 4 weeks of moderate to strong or at least 2 weeks of strong local glucocorticoid (TCS) treatment for AD before screening, with poor efficacy or intolerable Exclusion Criteria: 1. Acute onset of AD within the first 4 weeks of randomization. 2. Have participated in any clinical research on AK120 in the past 3. Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization. 4. Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer) 5. Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period. 6. Received allergen specific immunotherapy within the 3 months before randomization. 7. Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies. |
Country | Name | City | State |
---|---|---|---|
China | Baoji Central Hospital | Baoji | Shanxi |
China | Beijing Friendship Hospital Capital Medical University | Beijing | Beijing |
China | Beijing Luhe Hospital Affiliated to Capital Medical University | Beijing | Beijing |
China | Beijing Tongren Hospital | Beijing | Beijing |
China | Peking University People's Hospital | Beijing | Beijing |
China | Peking University Third Hospital | Beijing | Beijing |
China | The First Affiliated Hospital of Bengbu Medical College | Bengbu | Jiangsu |
China | The First Bethune Hospital of Jilin University | Changchun | Jilin |
China | Changde First People's Hospital | Changde | Hunan |
China | Xiangya Hospital of Central South University | Changsha | Hunan |
China | Changzhou First People's Hospital | Changzhou | Jiangsu |
China | Chengde Medical College Affiliated Hospital | Chengde | Hebei |
China | Sichuan Provincial People's Hospital | Chengdu | Sichuan |
China | Chongqing Three Gorges Medical College Affiliated People's Hospital | Chongqing | Chongqing |
China | Chongqing Traditional Chinese Medicine Hospital | Chongqing | Chongqing |
China | The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian |
China | The First Affiliated Hospital of Gannan Medical College | Ganzhou | Jiangxi |
China | Guangdong Provincial People's Hospital | Guangzhou | Guangdong |
China | Southern Medical University Dermatology Hospital/Guangdong Provincial Dermatology Hospital | Guangzhou | Guangdong |
China | Southern Medical University Southern Hospital | Guangzhou | Guangdong |
China | Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong |
China | The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong |
China | Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong |
China | The Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou |
China | Hainan General Hospital | Haikou | Hainan |
China | Hainan Provincial Fifth People's Hospital | Haikou | Hainan |
China | The First Affiliated Hospital of Hainan Medical College | Haikou | Hainan |
China | Hangzhou First People's Hospital | Hangzhou | Zhejiang |
China | Hangzhou Third People's Hospital | Hangzhou | Zhejiang |
China | The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang |
China | Harbin Medical University Affiliated Second Hospital | Harbin | Heilongjiang |
China | Heilongjiang Provincial Hospital | Harbin | Heilongjiang |
China | The First Affiliated Hospital of South China University | Hengyang | Hunan |
China | Inner Mongolia Medical University Affiliated Hospital | Hohhot | Inner Mongolia |
China | Jiaxing First People's Hospital | Jiaxing | Zhejiang |
China | Shandong Provincial Dermatology Hospital | Jinan | Shandong |
China | Shandong University Qilu Hospital | Jinan | Shandong |
China | The First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan |
China | The Second Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan |
China | Ningbo First Hospital | Ningbo | Zhejiang |
China | Ningbo Huamei Hospital, University of Chinese Academy of Sciences | Ningbo | Zhejiang |
China | Panjin Liaoyou Gemstone Flower Hospital | Panjin | Liaoning |
China | Qingdao Municipal Hospital | Qingdao | Shandong |
China | Shanghai Dermatology Hospital | Shanghai | Shanghai |
China | Yuebei People's hospital, Guangdong, China | Shaoguan | Guangdong |
China | Shenyang Integrated Traditional Chinese and Western Medicine Hospital | Shenyang | Liaoning |
China | Zhongyi Northeast International Hospital | Shenyang | Liaoning |
China | Shunde Hospital of Southern Medical University | Shunde | Guangdong |
China | Tianjin Institute of Traditional Chinese Medicine Affiliated Hospital | Tianjin | Tianjin |
China | Xinjiang Uygur Autonomous Region People's Hospital | Urumqi | Xinjiang |
China | Wenzhou Medical University First Affiliated Hospital | Wenzhou | Zhejiang |
China | Renmin Hospital of Wuhan University Hubei General Hospital | Wuhan | Hubei |
China | Tongji Hospital | Wuhan | Hubei |
China | The Second Affiliated Hospital of Xiamen Medical College | Xiamen | Fujian |
China | The Second Affiliated Hospital of Xingtai Medical College | Xingtai | Hebei |
China | Yancheng First People's Hospital | Yancheng | Jiangsu |
China | General Hospital of Ningxia Medical University | Yinchuan | Ningxia |
China | Guangdong Medical University Affiliated Hospital | Zhanjiang | Guangdong |
China | Jiangsu University Affiliated Hospital | Zhenjiang | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Akeso |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75 | Percentage of patients in both treatment group and placebo group who achieved EASI 75 at week 16. | at week 16 | |
Secondary | Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA | The percentage of patients in both treatment group and placebo group who achieved IGA 0/1 score at week 16. | at week 16 |
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